Z-0003-06

D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage

Name: Z-0003-06 D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage
Creator: B. Braun Medical, Inc.
Published: 2005-09-15
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2005-09-15 / Terminated / root cause: packaging

FDA source

B. Braun Medical, Inc. began a recall of D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage on 2005-09-15. The reason FDA records is "package sealing defect - product may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0003-06
Status: Terminated
Initiated: 2005-09-15
Posted: 2005-10-04
Terminated: 2006-03-23
Recalling firm: B Braun Medical Inc
Product: D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Product code: FRO Dressing, Wound, Drug
Reason for recall: package sealing defect - product may not be sterile
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 9/15/05 informing their accounts of the problem and the need to return the product.
Quantity in commerce: 60 units
Distribution: The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.
Product codes and lots: Lot numbers 301323A and 301393

Product code FRO

K030836UnclassifiedD-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. / cleared 2003-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)